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510(k) K021463

MODEL 1133 IVD PC VERSION by Sun Nuclear Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2002
Date Received
May 7, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Sun Nuclear Corp.

  • K112981 — SUN 125C IONIZATION CHAMBER (January 25, 2012)
  • K101992 — 3D SCANNER, MODEL 1230 (October 1, 2010)
  • K092019 — MODEL 1014 PC ELECTROMETER (September 15, 2009)
  • K063021 — PROFILER 2 (November 22, 2006)
  • K051921 — THE EDGE DETECTOR, MODEL 1118 (July 27, 2005)
  • K013689 — RE-ENTRANT CHAMBER (July 2, 2002)
  • K011332 — RF-IVD WIRELESS DOSIMETER-MODEL 1133 (July 26, 2001)
  • K011466 — QED DIODE DETECTORS, MODELS 1112-1116 (June 6, 2001)
  • K010449 — IVD (IN VIVO DOSIMETER), MODEL 1131 (May 4, 2001)
  • K002446 — RE-ENTRANT CHAMBER, MODEL 1008 OR 44D (October 23, 2000)

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